Hepatitis B vaccination of healthy adolescents.
Conditions
Interventions
Trade Name: Engerix-B Junior
Product Name: Engerix-B Junior
Product Code: HBV Paediatric 10
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: -
Current Sponsor code: HBsAg
Other descr
Sponsors
GlaxoSmithKline Biologicals
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A male or female between and including, 11 and 15 years of age at the time of the first vaccination. Written informed consent obtained from the subject and subject’s parent/guardian. Free of obvious health problems as established by medical history and clinical examination before entering the study. If the subject is female and of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after completion of the vaccination series. Subjects should be seronegative for HBs antigen, anti-HBc antibodies and anti-HBs antibodies. Are the trial subjects under 18? yes Number of subjects for this age range: 384 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Use of any investigational or non-registered drug or vac-cine other than the study vaccines within 30 days preced-ing the first dose of study vaccine, or planned to use during the study period. Administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of vaccine. Previous vaccination against hepatitis B. Known exposure to hepatitis B within the previous 6 weeks. History of hepatitis B infection. Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection. A family history of congenital or hereditary immunodeficiency. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. Acute disease at the time of enrolment. Hepatomegaly, right upper quadrant abdominal pain or tenderness. Administration of immunoglobulins and any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. Pregnant or lactating female. Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Any chronic drug therapy to be continued during the study period. Acute or chronic, clinically significant pulmonary, cardio-vascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests. Major congenital defects or serious chronic illness. History of chronic alcohol consumption and/or intravenous drug abuse. Female planning to become pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: For the primary Epoch: To demonstrate non-inferiority of the immune response induced by (thiomersal-free) Engerix™-B (20 mcg HBsAg) administered as a 2-dose vaccination schedule compared to (preservative-free) Engerix™-B (10 mcg HBsAg) administered as a 3-dose vaccination schedule, one month after the full vaccination course (month 7). For the long term follow-up (LTFU): To evaluate anti-HBs antibody persistence at Months 30, 42, 54 and 66 after the first vaccine dose of primary vac-cination. ;Secondary Objective: At months 1, 2 and 6: anti-HBs titers for all subjects. Occurrence, intensity of solicited local signs and symptoms during a 4-day follow-up (i.e. the day of vaccination and the 3 subsequent days) after each vaccination and overall. Occurrence, intensity and relationship to vaccination of general signs and symptoms during a 4-day follow-up (i.e. the day of vaccination and the 3 subsequent days) after each vaccination and overall. Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms within 30 days after each vaccination and overall. Occurrence, intensity and relationship to vaccination of serious adverse events during the study period, up to and including 30 days post-vaccination. ;Primary end point(s): Anti- Hepatitis B surface antigen (HBs) titers. Anti-HBs seroprotection (SP) rates (defined as the proportion of subjects with anti-HBs antibody titres >=10 mIU/ml). Anti-HBs antibody persistence.;Timepoint(s) of evaluation of this end point: For seroprotection rate: At Month 7 For anti-HBs antibody persistence: At Months 30, 42, 54 and 66. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Anti-HBs titers for all subjects. Occurrence, intensity of solicited local signs and symptoms. Occurrence, intensity and relationship to vaccination of general signs and symptoms. Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms. Occurrence, intensity and relationship to vaccination of serious adverse events.;Timepoint(s) of evaluation of this end point: For anti-HBs titers for all subjects: At Months 1, 2 and 6 For solicited local and general symptoms: During a 4-day follow-up (Day 0- Day 3) after each vaccination and overall. For unsolicited symptoms: Within 30 days (Day 0-Day 30) after each vaccination and overall. For serious adverse events: During the entire study period (Month 0 to Month 7). | — |
Countries
Australia, Ukraine
Contacts
Public ContactClinical Disclosure Advisor
GlaxoSmithKline Biologicals
Outcome results
None listed